The US Food and Drug Administration (FDA) issued leapfrog guidance for nonclinical testing and study design related to implanted brain-computer interface (BCI) devices in people with amputations or paralysis. Leapfrog guidance allows the agency to address emerging technologies that are early in development but appear likely to be of importance to public health.
The guidance, drafted in March 2019, says that non-clinical device testing can be used to demonstrate that potential risks have been mitigated before beginning a clinical study. In a rapidly evolving field, having clear direction early in the process may help device developers save money and reduce risk, said former FDA Commissioner Scott Gottlieb, MD, in 2019.
“[It] is considered a ‘leap-frog’ guidance because it helps bridge where we are today with innovations of tomorrow, providing our initial thoughts about regulatory considerations for an emerging health technology with the understanding that our recommendations are likely to evolve as the FDA works to finalize the guidance to account for public comments, technological developments, and new information,” Gottlieb said in reference to the initial draft.
“Our success in improving safety and driving innovation depends, in part, on our ability to quickly identify the potential for future technological breakthroughs that can alter the paradigm for how we approach certain medical challenges and advance these goals,” he said.
To read the guidance, “Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation-Non-clinical Testing and Clinical Considerations,” visit the FDA website.
